Walmart’s Expanded HIV Services Promise Increased Access

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

Editor's Note: The Blogger platform classifies any use of the word "p(h)armacy" as being a sales promotion. As a result of this erroneous classification, the word and its derivations will be typed using that format in order to avoid being flagged as a sales promotion.

In December 2022, Walmart announced that it would be expanding its Special P(h)armacies of the Community (SPOCs) to support communities with high rates of HIV to include stores in North Brunswick and North Bergen, NJ, Monticello, NY, and Hartford, CT. Those locations joined the initial three locations opened as part of their pilot program.

Since then, Walmart has opened an additional 70 locations, totaling 77 SPOCs located in Colorado, Connecticut, Florida, Georgia, New Jersey, New York, North Carolina, Texas, and Virginia. By the end of 2023, Walmart has promised more than 80 locations across eleven states.

According to their initial press release, Walmart claims that these SPOCs:

will help with all aspects of care, including industry-leading clinical programs, p(h)armacy services provided by HIV-trained p(h)armacists, enhanced care coordination, healthy lifestyle recommendations, and finding emotional support services from our Community Health Workers.

Walmart's SPOCs are located inside of individual p(h)armacies within the stores, ostensibly making the locations convenient to patients and those seeking HIV preventative care.

There are, it should be said, significant benefits to Walmart beyond just the good press.  Walmart has enormous opportunities to earn profits by accessing the 340B Drug Pricing Program’s inclusion of HIV medications. According to a 2019 report by Drug Channels, an estimated 25,000 p(h)armacies acted as contract p(h)armacies for hospitals and other covered entities that participate in the 340B program, and six large retail chains—Walgreens, CVS, Walmart, Rite Aid, Kroger, and Albertsons—account for two-thirds of 340B contract p(h)armacy locations.

In recent years, 340B program profits have soared with little to no oversight or enforcement, and we would be remiss if we didn't mention that Walmart stands to earn significant profits from serving as the contract p(h)armacy for People Living with HIV/AIDS (PLWHA), particularly in the markets they've chosen.

Which brings me to the next point:

As Walmart pointed out in its December 2022 statement, roughly 90% of the U.S. population lives within 10 miles of a Walmart location. They also state that these SPOCs provide “…an opportunity to reach people who might not otherwise have access to or seek out HIV care.”

And yet…the locations of these SPOCs are in areas of the country that already receive the bulk of federal funding for HIV testing, services, and treatment. Almost every location is in an urban or suburban population center—areas that often already have p(h)armacies specializing in HIV treatment and care.

It is obvious that these locations were chosen in accordance with the Ending the HIV Epidemic's (EHE) Phase 1 jurisdictions, which resulted in federal HIV funds being directed to the counties and cities where HIV incidence is highest. This methodology is all well and good, but it misses the larger scope of the HIV epidemic and fails to fill the gaps left by this federal funding "plan".

It is curious, then, that Walmart argues that these locations will "…reach people who might not otherwise have access to or seek out HIV care," when those areas are already glutted with services compared to other areas of the country. Looking at Orlando alone, there are 25 providers of care, and four dedicated p(h)macies dedicated to providing services to PLWHA.

If the purpose is to expand access, Walmart would be better suited to open SPOCs in farther-flung areas of those states, where patients are already required to travel more than 30 minutes to access HIV services. Opening a SPOC in Florida’s rural counties, such as Okeechobee, Hardee, DeSoto, Highlands, or Glades, would provide patients living outside of urban areas better access to care and services.

Beyond just the nine current and two potential states where Walmart's SPOCs have or will be opened, there are significant gaps in care and p(h)armacy services in states like Alabama, Kentucky, Mississippi, Tennessee, central and western Virginia, and West Virginia—areas that are largely rural, but have either significant existing populations of PLWHA or face increased risks of HIV transmission either through sexual contact or through Injection Drug Use.

To be clear, I am not being critical of Walmart for expanding services to be inclusive of PLWHA and those seeking preventative services. I am absolutely in favor of a "Yes, And" approach to HIV services provision. The addition of more providers has the potential to provide patients with more choices of where to receive care, and additional opportunities and points of care may allow patients to access services in places that are convenient to them. Additionally, increasing the number of providers has the potential to break HIV care outside of the longstanding monopolistic service provision models that exist both locally and nationally, where patients have been essentially forced to access care, treatment, and supportive services from providers because there hasn’t been anywhere else to go, even if those providers have treated them poorly, engaged in unethical practices, or provided services that aren't culturally competent or sufficient to meet the needs of their patient populations.

That said, Walmart, CVS, and Walgreens haven't really managed to make their locations places where patients—particularly those attempting to access sexual or reproductive healthcare services—feel safe accessing those services or openly discussing concerns with staff p(h)armacists. There’s a distinct lack of personal connection in highly corporate locations, and when you're dealing with fraught issues such as those presented with HIV care and treatment (or other chronic conditions), the last place you want to be if you're having a tough time dealing with issues is in the middle of a large shopping center surrounded by random people trying to find the potato chip aisle.

Overall, however, the expansion of Walmart's SPOC locations seems like a good thing, even if the locations they've chosen don’t really provide services that are novel to those areas. Time will tell whether or not they have any real impact.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Monoclonal Antibodies Reveal Promise for Viral Suppression Failure

By: Ranier Simons, ADAP Blog Guest Contributor

There are multiple treatment goals of HIV antiretroviral therapy (ART): “maximally and durably suppress plasma HIV RNA, restore and preserve immunologic function, reduce HIV-associated morbidity and prolong the duration and quality of survival, and prevent HIV transmission.”[1] Suppressing the HIV viral load to an undetectable status means reducing the levels of HIV in the blood so low that it cannot be detectable by blood assay tests. Usually, after starting ART, patients achieve viral suppression after 12-24 weeks of therapy.[1]

However, viral suppression is sometimes not maintained or achieved at all. Virological suppression failure happens in patients who initially contract drug-resistant strains of HIV, patients who have inadequate adherence to treatment regimens, those who acquire resistance over time after long-term treatment, and by nature of the pharmacokinetics and pharmacodynamics of the drugs in some patients’ bodies based on their genetics.[2] ART consists of drug cocktails of antiretroviral medications. Advancements in HIV research have resulted in many different ART medicines for patients. Thus, patients have other options to switch to when one regimen is unsuccessful. 

Unfortunately, there are patients who have exhausted many available avenues of therapy without achieving viral suppression. Ongoing research is looking into means by which to augment the current library of drug options as well as create new drugs. A recent study presented in May at the 2023 American Conference for the Treatment of HIV™ (ACTHIV™) is a promising development. ACTHIV™ is a conference dedicated to those on the frontline of treating HIV patients. The conference presents research and developments that can be directly integrated into the clinical setting.[3] 

Photo Source: New England AETC

The study involved the use of monoclonal antibodies as part of ART. Monoclonal antibodies are proteins synthesized in a lab that act like the antibodies we already produce. The monoclonal antibodies stimulate your immune system by binding to foreign invaders, such as viruses, to help your body attack them.[4] The subject of the study was a monoclonal antibody called ibalizumab, marketed by Theratechnologies as Trogarzo. Trogarzo is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor.[5] The FDA initially approved it in 2018 for treating adults with multi-drug resistant HIV with unsuccessful ART regimens.

This study was novel because it was the first one directly comparing ibalizumab with non-ibalizumab regimens. The clinical trials cohort data was compared to real-world population data of appropriately matched patients on non-ibalizumab-containing regimens. The non-ibalizumab control group was taken from a database called OPERA, an extensive electronic health record database with deidentified patient-level data encompassing around 14% of the total United States' HIV population collected at the point of care.[6] Results from 76 ibalizumab-treated patients from clinical trials were compared to 65 comparable non-ibalizumab-regimen patients from OPERA. 

Photo Source: POZ

Using ibalizumab sped up the time period to viral suppression compared to the control group. The data showed a doubling in the likelihood of viral suppression compared to the non-ibalizumab group.[6] Additionally, viral suppression was more robust. About 95% of the ibalizumab group stayed undetectable through the completion of the study, compared to 27% of those who achieved undetectable status without ibalizumab. The odds of losing viral suppression were 16 to 18 times higher in those in the non-ibalizumab group.[6] The most remarkable aspect of the results is that those in the ibalizumab group had more severe disease progression at the start of the study than those in the control group.[5] Yet they still had better outcomes.

The study solidified the clinical efficacy of using ibalizumab. This is promising because it legitimizes a pathway to develop similar ART tools in the future. It also proves the effectiveness of using databases like OPERA to comparatively study present and future innovations.

[1] NIH Office of AIDS Research. (2016, January 28). Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/treatment-goals

[2] Bessong, P.O., Matume, N.D. & Tebit, D.M. Potential challenges to sustained viral load suppression in the HIV treatment programme in South Africa: a narrative overview. AIDS Res Ther 18, 1 (2021). https://doi.org/10.1186/s12981-020-00324-w

[3] American Conference for the Treatment of HIV. (2023). https://acthiv.org/

[4] Cleveland Clinic. (2023). Monoclonal Antibodies. Retrieved from https://my.clevelandclinic.org/health/treatments/22246-monoclonal-antibodies

[5] Theratechnologies. (2023, May 4). Theratechnologies’ Trogarzo® (Ibalizumab-uiyk) Shortens Time to HIV Undetectability and Extends Durability of Undetectability and Viral Suppression in a Matched Treatment Comparison. Retrieved from https://www.theratech.com/news-releases/news-release-details/theratechnologies-trogarzor-ibalizumab-uiyk-shortens-time-hiv

[6] Feller, S. (2023, May 13). Monoclonal antibody speeds time to HIV viral suppression, study finds. Retrieved from https://www.healio.com/news/infectious-disease/20230512/monoclonal-antibody-speeds-time-to-hiv-viral-suppression-study-finds?utm_medium=social&utm_source=twitter&utm_campaign=sociallinks

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

What’s Needed to Fix a Vital Drug Discount Program

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Guy Anthony, Founder & President, Black, Gifted & Whole Foundation

****Reprinted with permission from POZ****

Thirty years ago, when Congress passed the Public Health Service Act, no one could have imagined that section 340B of the law would become the lightning rod that it is today. The little-known provision created a program to help America’s safety net health care providers bring affordable care and discounted medicines to vulnerable, low-income patients. 

Photo Source: POZ | iStock

The initial concept was simple and effective. Pharmaceutical manufacturers provide steeply discounted drugs to hospitals, providers, and clinics that serve uninsured and underinsured patients living with HIV/AIDS, and safety net providers dedicated to reaching the most vulnerable and underserved communities. The support that the 340B program provided to Ryan White Clinics and hemophilia treatment centers was critical in addressing the HIV/AIDS crisis through the 1990s. Today, when people living with HIV can successfully manage the disease with highly effective therapies, it remains essential.

But the program and the true safety-net clinics that rely on it is teetering on the brink of collapse due to statutory silence in key areas. It turns out that the attraction of using significant savings on medicines to boost profit margins has been irresistible to some for-profit entities, at the expense of the safety net. The for-profit entities dipping into the 340B program’s discounted prescription drugs now include, among others, well-resourced hospitals in wealthier zip codes, pharmacy benefit managers (PBMs), and a vast network of contracted pharmacies (also largely located in wealthier zip codes). The numbers on this point speak volumes: 340B discounted drug purchases amounted to $38 billion in 2020, more than 15 times what it was in 2005. As Congressman Bucshon noted, wouldn’t you expect a 15x increase in the amount of charity care that is available in this country?

The realities of how the 340B program is currently implemented is a clear indication that stronger accountability and transparency are urgently needed so that the program can begin to work as intended, and patients don’t continue to get left behind. Abuses of the program have been exhaustively documented by government watchdogs and others including analysis by an advocacy group for cancer patients that found that hospitals are overcharging patients for a common breast cancer drug. The research found that hospitals pay a discounted price of just over $43,000 for a year’s supply of the drug,   while charging patients over $217,000 for the same medicine, reaping a profit of more than $173,000 from just one patient, thanks to the program designed to help the nation’s poorest citizens. 

Patients are bearing serious consequences from the lack of clarity in the 340B program and the loss of critical resources safety-net providers depend on. As organizations that provide essential services and education for the HIV/AIDS community, we know this program must be better defined if it is to work as intended. We also know that Congress has a central role to play in making that happen. 

We can only achieve changes that work in the interest of the safety net if the diverse 340B community works together, rather than at odds with itself. That’s where the newly-formed Alliance to Save America’s 340B Program (ASAP 340B) comes into play. The Alliance’s 10 policy principles provide a critical foundation for Washington decision makers to change the trajectory of the program and improve administration and oversight at the federal level. The Principles are designed to ensure greater transparency and accountability; determine a “patient definition” with with stronger safeguards; establish clear criteria for 340B contract pharmacy arrangements to improve access; prevent middlemen and for-profit entities from profiting off the 340B program; and update and strengthen 340B hospital eligibility requirements.

Photo Source: ASAP 340B

Inaction will – not could but will – very soon have serious ramifications on the care that our community receives. Yet despite the diverse organizations that have come to the table to bring about change, not everyone agrees. A cacophony of voices – including some from the HIV community – has expressed concern or displeasure with the idea of bringing ideas to the table that would enhance transparency, accountability, and most importantly, deliver long-time certainty to the program. But notably, no comprehensive, viable alternatives have been offered. 

Congress and the administration have made it clear that making prescription drugs more affordable should be a major public health priority. Fixing the 340B program can move the needle on that goal, bringing health care affordability to our nation’s most underserved patients and communities.

This opinion piece was also published on June 7th in POZ.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

HRSA Offers Guidance on Buprenorphine

By: Ranier Simons, ADAP Blog Guest Contributor

There is a higher prevalence of substance use disorder (SUD) among people living with HIV/AIDS (PLWHA) compared to the population at large.[1] Among PLWHA, nearly 50 percent report a current or past history of substance use disorders (SUD).[2] As such, in May 2023, the HIV/AIDS Bureau of the Health Resources and Services Administration (HRSA) sent a letter to all Ryan White HIV/AIDS Program (RWHAP) Part B Aids Drug Assistance Program (ADAP) recipients encouraging them to include medications used to treat SUD in their formularies. HRSA additionally emphasized adding buprenorphine and naloxone.[3] 

Photo Source: HRSA

Buprenorphine is used to treat opioid addiction as an agonist treatment. It is a long-acting drug compared to the short-acting opioids to which people have addictions, such as heroin and oxycodone. Buprenorphine stays in the blood for 24-36 hours, in contrast to shorter-acting drugs people abuse that require consumption multiple times a day to prevent withdrawal symptoms.[4] Proper dosage of buprenorphine does not cause a euphoric high, and it allows substance abusers to stabilize their lives and gain control. Any drug can be abused and overdosed. However, an overdose of buprenorphine is less likely than an overdose of methadone, another medication used for agonist treatment. Naloxone is a drug that can temporarily reverse the effects of an opioid overdose giving a person time to allow medical assistance to arrive.

Roughly 40 percent of ADAPs do not have buprenorphine or naloxone on their formularies.[3] While most health insurance plans cover medications to treat SUD, 37.4 percent of ADAP patients have no health coverage.[3] Each ADAP determines the composition of its formulary. They use advisory boards of professionals to examine their populations and determine the cost/benefit analysis of including certain medications. ADAP clients without health insurance who also have SUD are left without the means to obtain SUD drugs that could drastically improve their lives.

PLWHA dealing with substance use addictions have poorer health outcomes than those without addictions. Drug abuse causes inconsistent antiretroviral adherence resulting in lower rates of viral suppression. SUD causes people to not engage in behaviors necessary for a productive, stable existence. Additionally, substance abuse can result in dangerous drug interactions between therapeutic medications and the drugs being abused, in addition to excessive wear on organs such as the liver and kidneys. To effectively fight the HIV/AIDS epidemic, it is vital to treat PLWHA wholistically. This means dealing with their mental and physical co-morbidities in addition to their HIV.

Photo Source: Baton Rouge Behavioral Hospital

The World Health Organization (WHO) also recognizes the importance of buprenorphine and naloxone. Both are listed on the 2021 22nd WHO model list of essential medicines, which is updated every two years. The essential medicine list are medicines: “that satisfy the priority health care needs of a population…selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safety and comparative cost-effectiveness…intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality and at prices individuals and health systems can afford…“[5] 

RWHAP's ADAP manual states that ADAPs may include medications used to treat chronic medical and mental health conditions in addition to some of the mandatory requirements, such as including at least one drug from each class of HIV antiretroviral medications.[6] If more ADAPs heed the suggestion of the HRSA letter, more PLWHA with substance addictions can get treatment and relief. Many ADAPs are facing funding challenges. However, including buprenorphine and naloxone would be worthwhile formulary additions as their usage is evidence-based.

[1] Shiau, S., Arpadi, S. M., Yin, M. T., & Martins, S. S. (2017). Patterns of drug use and HIV infection among adults in a nationally representative sample. Addictive behaviors, 68, 39–44. https://doi.org/10.1016/j.addbeh.2017.01.015

[2] Durvasula, R., & Miller, T. R. (2014). Substance abuse treatment in persons with HIV/AIDS: challenges in managing triple diagnosis. Behavioral medicine (Washington, D.C.), 40(2), 43–52. https://doi.org/10.1080/08964289.2013.866540

[3] HRSA. (2023, May 11). Ryan White Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/rwhap-partb-aids-drug-assistance.pdf

[4] Centre for Addiction and Mental Health. (2023). Buprenorphine. Retrieved from https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/buprenorphine#:~:text=Overview,pain%20relief%20for%20seven%20days

[5] World Health Organization. (2023). WHO model list of essential medicines - 22nd list, 2021. Retrieved from https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02

[6] HRSA. (2016). AIDS Drug Assistance Program Manual. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/resources/adap-manual.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Did South Carolina Just Weaken Patient Choice Protections for Specialty Drugs?

By: Ranier Simons, ADAP Blog Guest Contributor

An undeniable fact with largely universal consensus is that the United States needs healthcare reform. Healthcare reform is an overhauling of the healthcare system to achieve what the Institute for Healthcare Improvement describes as the Triple Aim: “improving the patient experience of care (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of health care.”[1] The Affordable Care Act (ACA) is the most recent attempt to reach the Triple Aim by increasing insurance access, mandating levels of quality, and trying to make healthcare more affordable. The challenge of healthcare reform is that healthcare is a system. By definition, a system has moving components that not only move independently but also are interdependent upon other parts of the system. Regarding healthcare, the moving parts of the system are smaller systems. South Carolina recently attempted to make some positive changes to the healthcare infrastructure in that state, though it is unclear if all the changes will actually benefit patients.

Photo Source: Greenville Legal

It is important to remember that regulation is one tool used to attempt the improvement of the many U.S. healthcare system components. Through legislative regulation, lawmakers try to create frameworks to optimize how various healthcare system component’s function. A significant component of healthcare is prescription medication. Pharmacies, pharmacy benefit managers (PBMs), and insurance plans are several players in the prescription medication system. Presently, the costs and availability of drugs are primarily controlled by PBMs. Insurance companies employ pharmacy benefit managers who control which drugs appear on plan formularies, negotiate the prices insurance plans pay for prescriptions, decide which pharmacies can participate in a plan’s network, and more.[3,5]

While many components within the U.S. healthcare system operate under detailed and enforced regulation, PBMs do not. They are largely unregulated. To maximize their profits, they participate in multiple practices that create challenges for insurance plans, pharmacies, and ultimately patients, driving up costs and creating inefficiencies in patient care.[3,5] South Carolina has been working through legislation to curtail and regulate the activity of PBMs - including Senate Bill 520 (SB520), part of the Pharmacy Audit Protection Act - which was recently passed by the state legislature.[2]

One of many excessive practices by PBMs to drive profit is pharmacy audit. A pharmacist with over 30 years experience providing care to patients living with HIV/AIDS summarized, “Pharmacists are constantly being audited by strong-arm PBMs. They often go after the high-cost drugs and deny claims for minor infractions. It’s a bullying tactic.” SB520 aims to protect pharmacies from unjust audits by PBMs. The bill defines explicitly the structure of what entity can be designated a PBM; it explains what PBMs operationally can and cannot do, defines the rights of pharmacies in general and in the face of a PBM audit, gives patients freedom of choice in utilizing in-network pharmacies, and much more. PBMs use numerous abusive audit practices to drive profit, including audit fees, denying claims for minor clerical errors forcing pharmacies to pay back money for drugs they were reimbursed, and making it difficult for pharmacies to re-bill PBMs after winning audit appeals.

Photo Source: Framework LTC

The bill is essentially a step in the right direction. However, multiple payers lobbied to add verbiage potentially adversely affecting HIV patients and others. Section 38-71-2245, subsection (A) states: “A pharmacy benefits manager may neither limit an insured from selecting an in-network pharmacy or pharmacist of the insured's choice nor deny the right of a pharmacy or pharmacist to participate in a network if the pharmacy or pharmacist meets the requirements for network participation set forth by the pharmacy benefits manager, and the pharmacy or pharmacist agrees to the contract terms, conditions, and rates of reimbursements.”[2]  This section protects patient choice of pharmacists. 

Payers asked for the following verbiage added to the section: 

“Notwithstanding subsection (A), a pharmacy benefits manager may, for specialized delivery drugs, specify requirements for network participation that: (1) directly relate to the ability of the pharmacy or pharmacist to store, handle, or deliver a prescription drug in a manner that ensures the quality, integrity, or safety of the drug, its delivery, or its use; or  (2) relate to quality metrics that affect a pharmacy's or pharmacist's ability to participate, provided that the pharmacy benefits manager applies such terms equally to all network participants. (C) For prescription drugs that qualify as a high-cost prescription drug, subsection (A) of this section does not apply to a pharmacy benefits manager. A high-cost prescription drug is defined as a prescription drug whose current or prior year's annual average wholesale price exceeded 300 percent of the Federal Poverty Level for a single-member household. (D) A pharmacy benefits manager must provide notification of any changes to all applicable specialized delivery drug lists and high-cost prescription drug lists and must make such lists available on a website and upon request to participating pharmacies. A pharmacy may appeal a classification determination to the Department of Insurance.”[2]

The verbiage states that patient choice protections do not apply to specialty or high-cost prescription drugs. In section 38-71-2200, the bill defines specialized delivery drugs as “a prescription drug that meets a majority of the following criteria, as set forth by the manufacturer, FDA, or other applicable law or regulatory body and: (a) requires special handling or storage; (b) requires complex and extended patient education or counseling; (c) requires intensive monitoring; (d) requires clinical oversight; or (e) requires product support services; and the drug is used to treat chronic and complex, or rare medical conditions  (i) that can be progressive; or (ii) that can be debilitating or fatal if left untreated or under-treated.”[2]

Given the broad definition of specialty and high-cost prescription drugs, the bill allows PBMs to manipulate how HIV antiretrovirals and related treatments are filled. The pharmacist consulted on this issue also explains, "It’s a way for PBMs to mandate that these prescriptions need to be filled from their central mail pharmacies. Since most HIV ARVs are oral and do not require special handling, access has commonly been allowed at retail. The high cost is what’s driving this change. Also, most independent pharmacies don’t mind not having to fill these drugs because of the high cost. For HIV-focused pharmacies, these prescriptions and patients will no longer have access to trained pharmacists and relationships with providers… will all go to mail and automation.” 

He further explains that: “In exchange for fewer audits on specialty drugs, since the retail pharmacies won't be filling them anymore, the managed care organizations will allow more access to more regular prescriptions at retail pharmacies, a move that a lot of non-specialty pharmacies like because it allows them to serve more patients. They’re trading away HIV patients for more ‘non-specialty’ patients.”

Photo Source: SNF Solutions

The bill's definition of “specialized delivery” drugs affects other types of drugs as well. Using the example of antibiotics for a UTI for an elderly person, Jen Laws, President & CEO of Community Access National Network (CANN), explains: “Under the requirements set forth, most antibiotics lose efficacy when exposed to high heat, might require education as to contraindications for patients with other co-occurring conditions, will require monitoring for clearance of infection, and these types of infections can be progressive or debilitating in elderly patients. And while this is an extreme example, it is possible under the bill as written. Given payer willingness to abuse carve-outs and loopholes in laws, it's egregious to define ‘specialty’ so broadly, especially as medicine becomes more and more personalized.”

Increased financial burden on HIV patients and providers is another bill outcome. ARVs are not always defined as specialty drugs on formularies, and thus, many times, they are on lower tiers of formularies that only require cost-sharing of fixed lower copays. Since the bill allows PBMs to define all ARVs as specialty drugs, they can move them to higher formulary tiers, which have much higher cost-sharing practices, such as significantly higher copays and coinsurance. This creates a significantly increased out-of-pocket financial burden on patients and covered entities that are covering the 340B patient copay cost.  

Compounding the increased financial burden is the usage of copay accumulators. Patients in the past who used manufacturer copay assistance programs could apply the copay card payments to their insurance deductible and out-of-pocket costs. Presently, many insurers use copay accumulators, which allow the copay assistance programs to pay the copays but do not allow the payments to count towards deductibles or out-of-pocket expense limits. Thus, the insurance companies are essentially being paid twice by requiring the insured to still must pay their deductibles and out-of-pocket limits after exhausting copay assistance cards. Additionally, patients are in danger of being unable to afford their medication since they would be responsible for paying the full price of their medications after the copay assistance was exhausted up until the limits of completely paying their deductibles.[4]

This bill is an example of the challenges of healthcare reform. It is easy for well-intentioned legislation to be tainted by opposing interests. It is imperative to be vigilant about whom we select as legislative representation and stay informed about legislation being written that affects our daily lives.

[1] Institute for Healthcare Improvement. (2023). The IHI Triple Aim. Retrieved from https://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

[2] South Carolina State House. (2023). S0520. Retrieved from https://www.scstatehouse.gov/sess125_2023-2024/bills/520.htm

[3] Royce, T., Schenkel, C., Kirkwood, K., Levit, L., Levit, K., Kircher, S. (2020). Impact of pharmacy benefit managers on oncology practices and patients. JCO Oncology Practice 16(5) 276-284. DOI: 10.1200/JOP.19.00606

[4] National Conference of State Legislatures. (2023, February 23). Copayment Adjustment Programs. Retrieved from https://www.ncsl.org/health/copayment-adjustment-programs#:~:text=When%20a%20patient's%20health%20plan,out%2Dof%2Dpocket%20maximums

[5] Healthcare Value Hub. (2018, January). Pharmacy benefit managers: Can they return to their client-centered origins? Retrieved from https://www.healthcarevaluehub.org/advocate-resources/publications/pharmacy-benefit-managers-can-they-return-their-client-centered-origins

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

An Expression of Support for Basic Human Decency

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Jen Laws, President & CEO, Community Access National Network

Earlier this week, ADAP Advocacy Association and Community Access National Network (CANN) issued a joint statement announcing an embargo of each respective organization’s patient advocacy and education activities within the state of Florida. Both organizations also cited a need to protect advocates and patients from outside of the state from the very real dangers associated with traveling to the state, while also emphasizing that both organizations will continue to support local advocates in the state as they work to create positive public policy changes for Floridians living with HIV. The decision to adjoin both the ADAP Advocacy Association and the Community Access National Network to the previously issued formal travel advisory by the NAACP wasn’t taken lightly because maintaining strong ties to the community is important in generating effective advocacy. The move was not a political statement either, but rather an expression of support for basic human decency.

The announcement comes after the state’s governor, Ron DeSantis, signed into law a series of bills targeted toward harming Black, Brown, LGBTQ+, and immigrant people. The transgender community was probably singled out more viciously than any of the marginalized communities throughout this hate-inspired Florida Legislative Session. Make no mistake about it why this effort to enflame a “culture war” is an issue of organizational values and something quite personal to both of us. The non-trans guy here taking issue with the fact that the trans guy here now cannot take “a leak” without fear of being charged with a felony has nothing to do with politics and everything to do with basic human rights.

The fact is we both previously lived in the state for many years – it’s where we started our HIV policy work, even before we knew one another. It is where we met over a decade ago. Upon reflection, we still can regularly be found discussing mutual friends from Florida, those still living and those who have passed on, in different phases of their lives.  

From recalling Bishop S.F. Makalani-MaHee's testimony to the Florida Legislature in 2016, against a bathroom bill (which failed that year), to his death on Transgender Day of Remembrance in 2017, part of this internal discussion was a reflection on the deep history he had with advocates serving both the Transgender and HIV communities of the state. What we’re witnessing right now in Florida is challenging for us, personally and professionally, but state-sponsored discrimination, hate, and stigma drew a line that cannot be ignored.

In 2017, Human Rights Watch published an important report, Living At Risk: Transgender Women, HIV, and Human Rights in South Florida, and the very same year ADAP Advocacy Association published it’s issue paper, Transgender Health: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS Under the AIDS Drug Assistance Program. Both of us worked on the ADAP project, and it was important for a transgender advocate (Jen) with lived experience to lead in writing model policies meant to serve Transgender People Living with HIV. The decision to issue a travel advisory in Florida for people living with HIV is rooted in disparities and areas of improvement emphasized in those two reports.

Photo Source: ADAP Advocacy Association

Much of our hearts belong to Florida for the dedication and innovation the people of this state can and do offer, despite every unnecessary public policy challenge they face. People like Mick Sullivan and Donna Sabatino (formerly with Tibotec Therapeutics), Connie Reese and her amazing work with Simply Amazing You Are (SAYA) in Miami-Dade County, Riley Johnson promoting trans equality in accessing medical care via RAD Remedy, Michael Ruppal’s leadership with The AIDS Institute, and the late Tiffany Marrero, who served to voice the experiences of vertical transmission patients and Black Women and only recently left us. Heck, Trelvis Randolph and Maria Mejia both reside in South Florida, and they serve on CANN’s board of directors. These folks not only are colleagues, but they are friends and expressing concern over traveling to a place once call “home” saddens us.

But some things are larger than us. Recognizing the inherent roots of racism, which has prompted the NAACP to issue a travel advisory, our joint statement read, in part:

The state of Florida's moves to harm Transgender people, Black and Brown communities, and immigrant families undermines the exceptional work the state's Health Department has done in the last several years and only serves to further existing health disparities affecting these communities, particularly as it relates to HIV. For example, according to Florida's own data, while Black and Hispanic/Latino communities make up about 15.6% and 26.7% of the state's population, respectively, these same communities represent 37.7% and 39.6% of HIV diagnoses. Put another way, in Florida, while white people experience a rate of HIV diagnoses of 8.5 per 100,000 people, that rate among Black communities is 51.8 and for Hispanic/Latino communities it's 31.7.

Similarly, Florida has, in years past, made extraordinary strides in ensuring transgender people can access HIV related care, specifically by integrating best practices and guidance from the Health Resources and Services Administration (HRSA) on integrating gender affirming care into HIV care provision. Indeed, as a result of these moves, transgender women represent some of the greatest successes in linkage to care, retention in care, and viral load suppression of any demographic in the state. Recently signed bills prohibiting state contracted clinics from providing gender affirming care will have a dramatic affect in reversing these long sought after wins. 

Make no mistake, we are frustrated with an apparent lack of involvement from the federal agency charged with implementing the Ryan White HIV/AIDS Program. Because Ryan White program dollars are passed through the state and then contracted with counties, local areas, or directly with a provider, and because other health initiatives of the state are also part of how providers in Florida acquire funding to provide public health services, they may be prohibited from providing gender affirming care at all - regardless of where those dollars originate (state or Federal).

It is incumbent upon HRSA to provide guidance beyond ‘allowable’ uses and inform that state it has contractual, fiduciary responsibilities associated with its grant and subrecipient contracts to ensure these dollars serve these communities. HRSA must move beyond the language of ‘allowable’ uses to ‘expected integration of best practices.’

In many situations, we have been willing and able to confront harsh environments. Indeed, we recognize the need to be present in the spaces where political forces wish to silence us. However, Florida has crossed a line in becoming hostile to the very existence of Black and Brown and Immigrant and Transgender people, those same communities most affected by HIV. The people who enacted these hateful laws were motivated by hateful politics; our response is motivated by concern for the people we’re charged with representing in our community…many of whom feel silenced. This is a line which we cannot cross and still consider ourselves as living the values we espouse.

We came to the difficult decision that neither the ADAP Advocacy Association or Community Access National Network will host any advocacy or educational event in the state of Florida. We will continue to support local advocates and people living with HIV residing in the state, including scholarship support for intrastate travel by local advocates. We will continue to offer analysis on the state's activities. But we will not ask advocates from outside of the state to risk their mental health or physical safety to travel to the state.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Affordable Care Act Marketplace Plans & Drug Benefit Design

By: Ranier Simons, ADAP Blog Guest Contributor

Healthcare insurance policy and finance are not abstract entities relegated to the arenas of political debate and Wall Street discourse. The convoluted machinations of how money flows in healthcare insurance finance affect the bank account of anyone who has ever been prescribed a prescription drug. People living with HIV are very aware of the importance of understanding how insurance operates regarding paying for expensive antiretroviral medications that cost thousands of dollars per month. 

Photo Source: Sciworthy

When choosing insurance plans, one of the most important aspects people living with HIV/AIDS (PLWHA) consider is how or if a particular plan covers their anti-retroviral (ARV) therapy. AIDS Drug Assistance Programs (ADAP) also pay close attention to drug coverage and drug pricing, given that they help provide medications to those who are uninsured as well as those who are underinsured. The Affordable Care Act (ACA) has enabled many PLWHA to access lifesaving medicines. However, the drug benefit design of many qualified health plans (QHP) participating in the ACA Marketplaces can hinder expeditious access to efficacious drugs.

A recent study examined how insurance benefit design affects antiretroviral access. The study focused on the changes in insurance coverage of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (dolutegravir/abacavir/lamivudine). These two drugs are first-line single-tablet regimens that have proven to be very effective. The U.S. Food & Drug Administration (FDA) approved Triumeq in 2014 and Biktarvy in 2018. Current treatment guidelines suggest that PLWHA start ART as soon as possible upon diagnosis, same day if possible. However, the study showed that access to novel treatments, such as Triumeq and Biktarvy, is slowed by delayed QHP coverage and benefit design.[1]

Photo Source: Rohan Khazanchi, MD, MPH | Twitter

The study assessed individual and small-group QHPs’ responses to the two new regimens. For the years 2018-2020, researchers examined coverage, cost sharing, specialty tiering, prior authorization (PA), and out-of-pocket (OOP) costs for Triumeq and Biktarvy nationally under QHP’s. Coverage refers to if a plan does or does not offer a drug in its formulary. Cost sharing refers to copays and coinsurance for drugs. A copay is a set fee patients pay for a prescription, whereas coinsurance is a percentage of a drug’s wholesale cost. Specialty tiering is the designation insurance drug formularies give to medications based on their costs. The higher the tier, the more of the costs are passed onto the consumer. More expensive drugs, such as ART, are in the higher tiers. Prior authorization is the bureaucratic process requiring healthcare providers to get pre-approval from a health plan before a drug is prescribed for the patient to qualify for payment coverage.

For 2018, 2019, and 2020, respectively, the study identified 19,533, 17,007, and 21,547 QHPs.[1] Overall, in 2018, 93% of the QHPs covered Triumeq, but only 60% covered Biktarvy. Triumeq coverage increased to 97% in 2019 and decreased to 91% in 2020. Biktarvy coverage decreased to 59% in 2019 but sharply increased to 86% in 2020. Concerning coinsurance, over the entire study period, a higher percentage of QHP’s required coinsurance for Biktarvy than Triumeq. The study also explicitly assessed coverage comparisons in EHE (Ending the HIV Epidemic Initiative) Phase I priority jurisdictions. Overall, across all three years studied, in both EHE and non-EHE jurisdictions, more QHPs covered Triumeq than Biktarvy. Interestingly, Biktarvy QHP coverage in 2020 was higher in EHE jurisdictions (90%) compared to non-EHE jurisdictions (85%). Biktarvy coverage in EHE jurisdictions increased from 74% in 2018 to 90% in 2020 due to increased coverage with coinsurance and copays. The study also found differences in prior authorization requirements. The prevalence of PA requirements for Triumeq was very low (2%, 2%, and 1% for 2018, 2019, and 2020, respectively).[1] PA prevalence was higher for Biktarvy, with 5% in 2018 and 8% in 2019. In 2020 all QHP had eliminated Biktarvy PAs except for 18 plans in Washington State.

Photo Source: HIVinfo

A multi-center, phase 3, double-blind, randomized control clinical trial of treatment naïve PLWHA showed that Biktarvy had the efficacy of viral suppression equal to Triumeq.[2,3] Additionally, it showed that Biktarvy had no evidence of treatment-emergent resistance and was better tolerated gastrointestinal due to its formulation and smaller pill size. Moreover, Biktarvy does not contain abacavir and thus does not require HLA-B*5701 testing making it a good candidate for same-day ARV initiation.[1] 

Evidence-based data showed Biktarvy to be a better candidate for first-line drug treatment for many than Triumeq. Yet, as stated previously, QHPs lagged in coverage of Biktarvy compared to Triumeq, even in EHE priority-1 jurisdictions. There were higher OOP costs given that more QHP’s required coinsurance for Biktarvy, and PA requirements were also initially more frequent for Biktarvy.

The critical takeaway from the study is that QHPs can slow the adoption of new HIV single-pill regimens by non-coverage decisions and other hurdles that limit access.[1] This does not stop at single-pill regimens. Ongoing HIV research continues to produce novel and innovative treatments such as Cabenuva and Sunlenca. Insurance companies base their coverage decisions mainly on the costs of the medications. Strident efforts are needed to create regulations to lower drug pricing. Additionally, cost-sharing measures need to evolve, such as basing patient coinsurance on post-PBM discounted drug prices instead of pre-discounted prices.[1] 

Increasing the pricing of novel and effective medication challenges ADAP’s ability to continue to help people. Additionally, prohibitive OOP costs for patients discourage medication adherence and treatment initiation. Many structural barriers to HIV treatment equality exist. Runaway pharmaceutical pricing and insurance drug coverage that is not scientifically evidence-based should not be amidst those barriers.

[1] Khazanchi, R., Powers, S., Killelea, A. et al. Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018–2020. J of Pharm Policy and Pract 16, 57 (2023). https://doi.org/10.1186/s40545-023-00559-8

[2] Acosta RK, Willkom M, Martin R, et al. Resistance analysis of Bictegravir–Emtricitabine–Tenofovir Alafenamide in HIV-1 treatment-naive patients through 48 weeks. Antimicrob Agents Chemother. 2019;63(5):e02533-18. https://doi.org/10.1128/AAC.02533-18

[3] Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825–32. https://doi.org/10.1097/QAD.0000000000002124

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.